SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep. 24, 2015--
Exelixis, Inc. (NASDAQ:EXEL) today announced three high-level
appointments as the company prepares for the potential commercialization
of its lead compound, cabozantinib, for the treatment of advanced renal
cell carcinoma (RCC) following positive results from the METEOR pivotal
phase 3 trial. William Berg, M.D. has joined the company as Senior Vice
President of Medical Affairs, Jonathan Berndt as Vice President of
Sales, and Gregg Bernier as Vice President of Marketing.
“Exelixis is moving rapidly to thoughtfully expand our medical affairs
and commercial capabilities in advance of our planned U.S. and EU
regulatory filings for cabozantinib in advanced renal cell carcinoma in
late 2015 and early 2016, respectively,” said Michael M. Morrissey,
Ph.D., president and chief executive officer of Exelixis. “Will, Jon,
and Gregg bring a wealth of oncology experience and successful track
records gained at some of the biopharmaceutical industry’s most
prestigious companies. Their new roles on the Exelixis team will help to
ensure we are well-positioned to execute on our many critical milestones
in the months to come.”
As Senior Vice President of Medical Affairs, William Berg, M.D. will
oversee medical affairs in the United States. He joins Exelixis after
spending more than 12 years at Novartis, where he served in roles of
increasing responsibility, including vice president and franchise head
within Global Medical Affairs. Notably, Dr. Berg led the Afinitor®
Medical Affairs program which was instrumental in the development of
Afinitor® in advanced RCC. Prior to Novartis, he was a
director of U.S. medical affairs at Aventis Oncology. Before entering
the pharmaceutical industry, Dr. Berg served on the faculty of the
Memorial Sloan Kettering Cancer Center (MSKCC), where he saw patients as
part of the Genitourinary Oncology Service, contributed to the MSKCC
risk model for advanced RCC, and researched novel therapies for the
disease. Dr. Berg completed his fellowship in medical oncology at MSKCC,
training under Robert J. Motzer, M.D. He earned his medical degree from
Cornell University Medical College and his Bachelor of Science from Duke
University.
Vice President of Sales Jonathan Berndt will lead all sales activities
for cabozantinib and also direct U.S. co-promotion efforts for
cobimetinib, including Exelixis’ plans to field up to 25 percent of the
cobimetinib U.S. sales force in the event of a potential regulatory
approval later this year. Mr. Berndt joins Exelixis with two decades of
commercial sales experience in the biopharmaceutical industry, including
multiple oncology product and line extension launches. Most recently, he
served as senior director, oncology sales at Gilead Sciences, where he
assembled and led the company’s oncology sales team supporting Zydelig®.
Prior to Gilead, Mr. Berndt served at Genentech for 13 years. While
there, he served in a variety of roles, including directing national and
regional sales for products including Rituxan® and Avastin®,
and managing sales operations for Herceptin® and Tarceva®.
He received his Bachelor of Science in management from Virginia Tech.
Exelixis’ new Vice President of Marketing Gregg Bernier will lead the
marketing group in its commercialization of cabozantinib for RCC. Mr.
Bernier has more than 20 years of experience in biotech and
pharmaceutical sales and marketing, primarily in oncology. Prior to
joining Exelixis, he served as senior director of marketing at
Medivation, where he led the launch of Xtandi® for a new
indication in metastatic castration-resistant prostate cancer. Mr.
Bernier joined Medivation from Genentech, where he worked on a variety
of product launches including Tarceva®, Kadcyla®,
Erivedge® and Avastin®, among other products. He
has also held positions at Pharmacia and Sanofi. Mr. Bernier received
his Bachelor of Arts in advertising at Michigan State University.
The new appointments come as Exelixis prepares U.S. and EU regulatory
filings for cabozantinib in advanced RCC, and awaits a U.S. regulatory
decision on its partner Genentech’s application for cobimetinib. In
July, Exelixis announced top-line results from METEOR, its phase 3
pivotal trial comparing cabozantinib to everolimus in 658 patients with
metastatic RCC who have experienced disease progression following
treatment with a VEGF receptor tyrosine kinase inhibitor. Cobimetinib,
the Exelixis-discovered selective inhibitor of MEK, was recently
approved in Switzerland for use in combination with vemurafenib as a
treatment for patients with advanced melanoma, and has a Prescription
Drug User Free Act action date of November 11, 2015 in the United
States. If cobimetinib is approved in the United States, Exelixis is
entitled to an initial equal share of U.S. profits and losses, which
will decrease as sales increase, and will share in U.S. marketing and
commercialization costs. Having exercised its option to co-promote the
compound in the United States, Exelixis is prepared to field up to 25
percent of the U.S. sales force.
About Exelixis
Exelixis, Inc. is a biopharmaceutical company committed to developing
small molecule therapies for the treatment of cancer. Exelixis is
focusing its development and commercialization efforts primarily on
cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine
kinases. Another Exelixis-discovered compound, cobimetinib, a selective
inhibitor of MEK, received its first regulatory approval in Switzerland
and is being evaluated by Roche and Genentech (a member of the Roche
Group) in a broad development program under a collaboration with
Exelixis. For more information, please visit the company's web site at www.exelixis.com.
Forward-Looking Statements
This press release contains forward-looking statements that are subject
to risk and uncertainty, including, without limitation, the therapeutic
and commercial potential of cabozantinib and cobimetinib as new
treatment options for second-line RCC and advanced melanoma patients,
respectively; the potential for regulatory filings, advancement and
eventual approvals for cabozantinib and cobimetinib, as stated, in the
U.S. and EU; whether Exelixis will be well-positioned to execute on
critical milestones in the months to come; the plan of Genentech and
Exelixis to share U.S. profits and losses and U.S. marketing and
commercialization costs for cobimetinib; Exelixis’ potential receipt of
royalties on sales of cobimetinib products outside the U.S.; and,
Exelixis’ preparedness to support U.S. co-promotion efforts for
cobimetinib in the U.S. Words such as “expand,” “in advance”, “planned”,
“will”, “ensure”, “execute”, “months to come”, “prepare”, “await”, “if”,
and “entitled” or other similar expressions identify forward-looking
statements, but the absence of these words does not necessarily mean
that a statement is not forward-looking. In addition, any statements
that refer to expectations, projections or other characterizations of
future events or circumstances are forward-looking statements. These
forward-looking statements are based upon Exelixis’ current plans,
assumptions, beliefs, expectations, and projections. Actual results and
the timing of events could differ materially from those anticipated in
the forward-looking statements, which include, without limitation: risks
related to the clinical, therapeutic and commercial potential of
cabozantinib and cobimetinib; risks related to Exelixis' ability to
build corporate and commercial infrastructure, including integrating new
capabilities, such that it is able to execute its plans effectively;
risks and uncertainties related to regulatory review and approval
processes and Exelixis' compliance with applicable legal and regulatory
requirements; risks related to market competition, changes in economic
and business conditions, and other factors discussed under the caption
“Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on August 11, 2015, and in
Exelixis’ other filings with the SEC. The forward-looking statements
made in this press release speak only as of the date of this press
release. Exelixis expressly disclaims any duty, obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change in
Exelixis’ expectations with regard thereto or any change in events,
conditions or circumstances on which any such statements are based.
Exelixis, the Exelixis logo, and COMETRIQ are registered U.S.
trademarks.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150924005195/en/
Source: Exelixis, Inc.
Investor Contact:
Exelixis, Inc.
Susan
Hubbard, 650-837-8194
Investor Relations and Corporate
Communications
shubbard@exelixis.com
or
Media
Contact:
For Exelixis, Inc.
Hal Mackins,
415-994-0040
hal@torchcommunications.com